This article is more than 5 years old. Information may no longer be current.
AAP, ACOG respond to FDA warning on sedation drugs, general anesthetics
Representatives from several leading medical groups indicated that despite the FDA placing warnings on 11 sedatives and anesthetics, doctors and patients can still consider using these same drugs.
The FDA’s warning came after animal studies suggested the possibility of long-term effects on animals’ behavior and learning when the subjects were exposed to the drugs, including halothane (Piramal Critical Care); Nembutal (pentobarbital, Oak Pharmaceuticals); Diprivan (propofol, Fresnius Kobi USA; and Ketalar (ketamine, PAR Sterile Products), for more than 3 hours. The warning was especially intended for women in their third trimester of pregnancy, and children aged 3 and younger who must use the medications on a long-term basis.
Raeford E. Brown, Jr., MD, FAAP, and Rita Agarwal, MD, FAAP, both of AAP’s Section on Anesthesiology and Pain Medicine, said the FDA’s findings should be put in perspective.
“The potential risk of negative cognitive or behavioral effects of anesthetic agents remains uncertain and must be placed in the context of the known risks and benefits of both the anesthetic and the related surgical or diagnostic procedure for which the anesthetic is required,” they wrote in a response that appeared on AAP’s website. “Until additional information is available from ongoing studies, parents and providers should carefully weigh the risk and benefit of each contemplated procedure before proceeding.”
The AAP also pointed out that three FDA advisory committees have discussed the findings mentioned in the warnings in the past 10 years, but new concerns were raised about whether all practitioners that use these drugs were aware of the findings.
“This warning appears to have been issued to raise awareness among practitioners and the public to ensure the information needed to make informed judgments about the risks and benefits of anesthesia and sedation in young children and pregnant women is widely available,” Brown and Agarwal wrote.
The AAP’s response was endorsed by the Society for Pediatric Pain Medicine, Pediatric Anesthesia Leadership Council, Congenital Cardiac Anesthesia Society, Society for Pediatric Anesthesia, Society for Obstetric Anesthesia and Perinatology, the International Anesthesia Research Society and the American Society of Anesthesiologists.
The American College of Obstetrics and Gynecologists (ACOG) also responded to the warning, saying pregnant women need to remember the FDA used animal tests as the basis for its decision, and the exposure time to the drugs in the studies was 5 to 24 hours; not the 3 hours described in the warning.
“Due to these substantial data limitations, ACOG maintains that women in any trimester of pregnancy should be counseled regarding evidence-based benefits and risks of any proposed interventions which may involve the use of general anesthetic or sedative agents. No women should be denied a medically indicated surgery or procedure which may involve the use of these agents,” Thomas Gelhaus, MD, ACOG President, said in a statement.
He also pointed out that very few patients would be subjected to the drugs for the time period in the warning.
“It is extremely unlikely that a pregnant woman or fetus would be exposed to these drugs for the time period described as potentially harmful for either an obstetric or non-obstetric surgery. In the event of prolonged anesthetic exposure due to a complicated delivery, the fetus would be delivered long before the potentially harmful range would be reached,” Gelhaus stated.
Disclosure: Agarwal and Brown are with AAP; Gelhaus is president of the ACOG.
Further reading:
https://www.aappublications.org/news/2017/01/10/Anesthesia011017